Health Canada clarified RUO policy
Health Canada said that any devices or diagnostic supplies labeled “for research use only” (RUO) cannot be used for clinical trials or for clinical diagnostic purposes. However, the agency said it has made an exception for tests and other devices for the COVID-19 pandemic, assuming the sponsor has provided a submission for commercial testing and/or validation of the device. The agency will screen any device or component for qualification under this policy by examining any printed or electronic materials, along with information on performance characteristics. Any device that does not meet one or more of these requirements and/or exceptions will be deemed marketed without authorization.